GUARDIAN & JANITEX CONDOM/PROPHYLACTIC— 510(k) K896098

Name: FDA 510(k) clearance K896098
Creator: U.S. Food and Drug Administration
Published: 1990-12-19

Substantially Equivalent

Allied Rubber Industries Sdn. Bhd.

FDA 510(k) clearance K896098 for GUARDIAN & JANITEX CONDOM/PROPHYLACTIC, Substantially Equivalent on 1990-12-19. Applicant: Allied Rubber Industries Sdn. Bhd.. Device class: 2.

Clearance details

Applicant: Allied Rubber Industries Sdn. Bhd.
Product code: Code HIS
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 1989-10-20
Decision date: 1990-12-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: 400000 Shah Alam.Malaysia, MY

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.